Status:
COMPLETED
Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying nerve function in older diabet...
Detailed Description
OBJECTIVES: Primary * Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens. * D...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of solid tumor
- Metastatic disease (stage IV)
- Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following:
- Taxane (paclitaxel or docetaxel)
- Platinum (cisplatin, carboplatin, or oxaliplatin)
- Diagnosis of type I or II diabetes mellitus
- PATIENT CHARACTERISTICS:
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No other disease that reduces peripheral nerve function (e.g., HIV/AIDS, uremia, spinal injuries, alcoholism, or CNS problems)
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- See Disease Characteristics
- No prior chemotherapy
- No prior or concurrent neurotoxic drugs (i.e., vincristine)
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00263861
Start Date
March 1 2005
End Date
September 1 2007
Last Update
June 11 2010
Active Locations (1)
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1
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5047